Profile: CT Lung Nodule Volume Measurement for Primary/Regional Nodes and Metastatic Sites

Please review and consider:

• are the claims appropriate, useful, sufficient
• would it make sense to move any claims to a different profile

Note: V-Cursor = Precursor Question about validating a Profile Claim; D-Cursor = Precursor Question about determining a Profile Detail

QIBA Profile: CT Lung Nodule Volume Quantification

Profile Claims (what users will be able to achieve)

Claim: Can create, store, retrieve images of lung nodules

V-Cursor: None; proven DICOM

Claim: Can create, store, retrieve linear, area and volume measurements made on lung nodule images

V-Cursor: None; proven DICOM

Claim: Can achieve accuracy of X and repeatability of Y

V-Cursor: Demonstrate this accuracy and repeatability is easily achievable

<Insert link to relevant Groundwork>

Profile Details (what equipment and users must do to achieve it)

The profile defines the following roles and several transactions and activities they participate in:

• Acquisition System
• Measurement System
• Measurer
• ...

Activity: Acquisition System Calibration

... <If determined to be necessary>

Activity: Image Acquisition

Detail: The acquisition system shall support saving and using saved acquisition protocols

Detail: The acquisition system shall support configuration of the following acquisition parameters

D-Cursor: What acquisition parameters matter? (kVp, mA, …)

<Insert link to relevant Groundwork>

D-Cursor: What value ranges constitute an acceptable “baseline”?

<Perhaps tie ranges to performance levels, e.g. Level 2 parameters might be sufficient for 1cm+ nodules, but Level 3 parameters are required for less than 1cm nodules>

Detail: The acquisition system shall produce images with the following characteristics

D-Cursor: What image characteristics matter? (resolution, noise level?)

<Insert link to relevant Groundwork>

Transaction: Transfer Images

Detail: The acquisition system shall support DICOM CT Storage as SCU.

Detail: The measurement system shall support DICOM CT Storage as SCP and DICOM Q/R as SCU

Activity: Measurement

Detail: The measurement system shall support the following measurements:

D-Cursor: What measurements are useful for evaluating lung nodules

• Bitvol <because it is the typical “detailed” volume measurement>
• RECIST <because it is the current gold standard and we need it to compare>
• Modified RECIST (J. Natl. Cancer Inst. 2008;100:698-711) <to support wider cancer etiology than HCC>

<consider just adding a bunch of tools if they are easy to implement>

D-Cursor: What accuracy is initially sufficient to be useful?

D-Cursor: What repeatability is initially sufficient to be useful?

D-Cursor: What accuracy/repeatability can be easily achieved?

<Insert link to relevant Groundwork>

D-Cursor: What is the theoretical limit for accuracy/repeatability with typical equipment

<Insert link to relevant Groundwork>

Detail: The measurer shall …

QIBA Profile: CT Lung Nodule Volume Change

This profile presumes the CT Lung Nodule Volume Quantification Profile is already supported by the participating systems.

Profile Claims (what users will be able to achieve)

Claim: Can determine tumor volume change based on comparison of measurements from multiple studies

V-Cursor:

Claim: Can achieve change accuracy of X and repeatability of Y

V-Cursor: Demonstrate this accuracy and repeatability is easily achievable

<Insert link to relevant Groundwork>

QIBA Profile: CT Lung Nodule Response

This profile presumes the CT Lung Nodule Volume Change Profile is already supported by the participating systems.

Profile Claims (what users will be able to achieve)

Claim: Can determine tumor "response" based largely on a change in measured volume

V-Cursor: Demonstrate that tumor response is adequately correlated with volume change

<Insert link to relevant Groundwork>

Claim: Can achieve a certain degree of confidence.

V-Cursor:

<Insert link to relevant Groundwork>

Profile Details (what equipment and users must do to achieve it)

D-Cursor: What other details must also be recorded

To Do

• Split other profiles to separate pages once the structure/content stabilizes a bit
• Review standard requirements traceability structures to see if they can help/be used
• Consider regrouping the Details under the Roles rather than Activities if that makes it clearer what each system or person must do to comply.